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Surgical Intervention for Morbidly Obese Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00289705
Recruitment Status : Unknown
Verified February 2017 by Göteborg University.
Recruitment status was:  Active, not recruiting
First Posted : February 10, 2006
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Göteborg University

Study Description
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Brief Summary:

The purpose is to study whether the positive effects from obesity surgery in adults also can be achieved when adolescent subjects are operated.

Our hypothesis is that the effects concerning weight loss, health improvement and improved quality of life will be as good in adolescents as in adults.


Condition or disease Intervention/treatment Phase
Obesity Diabetes Hypertension Procedure: Surgery Phase 3

Detailed Description:

Severe obesity in the adolescence is a major concern since there is a constant rise in prevalence worldwide. There is a need of effective tools to treat those patients since the natural course with conservative treatment is very pessimistic. I. e. most of the subjects having a BMI >40kg/m2 in the adolescence will remain morbidly obese also in their adult life.

The three largest centres in Sweden treating obese children (Stockholm, Gothenburg and Malmö) will offer patients fulfilling the inclusion criteria to be operated with laparoscopic gastric bypass. If not willing to be operated they could join the study as a control case.

Subjects will be investigated at the baseline concerning physical health status and existence of medical risk factors but also regarding their quality of life, eating habits and physical activity. They will subsequently be follow over a ten year period regarding these variables.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Intervention With Laparoscopic Roux-en-Y Gastric Bypass for Morbid Obesity in Adolescence - a Matched Control Study
Study Start Date : February 2006
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Surgery
Laparoscopic gastric bypass
 Procedure: Surgery
Laparoscopic Roux-en-Y gastric bypass
No Intervention: 2
Traditional treatment for obesity


Outcome Measures
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Primary Outcome Measures :
  1. BMI development [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Medical risk factors, incidence of diseases (such as diabetes, hypertension etc), quality of life, socioeconomic development, eating pattern. [ Time Frame: 10 years ]

Eligibility Criteria
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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI >40 kg/m2 or BMI>35 with comorbidity
  • Pass psychological evaluation
  • Puberty status Tanner 4-5
  • At least one year with active conservative treatment that failed

Exclusion Criteria:

  • Lack of compliance
  • Specific obesity syndrome as Praeder Willis
  • Obesity due to brain injury
  • Severe general disease
  • Specific genetic defect (MC4R, Leptin deficiency)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289705


Locations
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Sweden
Queen Silvias Children Hospital
Gothenburg, Göteborg, Sweden
Sahlgrenska University Hospital, Dept of Surgery
Gothenburg, Sweden, 41345
Dept of Pediatrics, MAS
Malmö, Sweden
National center for child obesity, Karolinska Huddinge
Stockholm, Sweden, 14186
Sponsors and Collaborators
Göteborg University
Investigators
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Principal Investigator: Torsten Olbers, MD, PhD Sahlgrenska University Hospital, Sweden
Study Chair: Clude Marcus, Prof, MD Dept of Pediatrics, Karolinska University Hospital, Huddinge
Study Chair: Staffan Mårild, MD, PhD Queen Silvias Childs Hospital, Gothenburg
Study Chair: Carl-Erik Flodmark, MD, PhD Dept of Pediatrics, MAS, Malmö
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT00289705    
Other Study ID Numbers: SU523-04
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017
Keywords provided by Göteborg University:
Obesity
Surgery
Adolescent
Roux-en-Y gastric bypass
Laparoscopic
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight